Medical Devices and IVDs

Factsheet for manufacturers of medical devices

November 2018

Basic information targeted at medical device manufacturers, including FAQs.

Step-by-step guide for medical device manufacturers

November 2018

Step-by-step list of points to consider and actions to take, targeted at medical device manufacturers.

Factsheet for manufacturers of in vitro diagnostic medical devices

November 2018

Basic information targeted at manufacturers of in vitro diagnostic medical devices, including FAQs.

Step-by-step guide for manufacturers of in vitro diagnostic medical devices

November 2018

Step-by-step list of points to consider and actions to take, targeted at manufacturers of in vitro diagnostic medical devices.

Factsheet for the procurement ecosystem

November 2018

Basic information targeted at the medical device procurement ecosystem, including FAQs.

Factsheet for competent authorities in non-EU/EEA countries

November 2018

Basic information targeted at medical device competent authorities in third countries, including FAQs.

Factsheet for authorised representatives / importers / distributors

November 2018

Basic information targeted at authorised representatives /importers/ distributors of medical devices, including FAQs.

Factsheet for healthcare professionals and healthcare institutions

June 2019

Basic information targeted at healthcare professionals and healthcare institutions, including FAQs.